Pharmaceutical and life sciences
Clinical trial translation and verification
- 'Does this Dutch ICF follow the current master version and country template?'
- 'Has every date, dose and visit window carried across correctly?'
- 'Is any text still untranslated before we submit?'
TRUSTED BY
Case Studies
Translation Services
Translation for a multinational clinical trial in EMEA
The client and the project are anonymised throughout.
Read MoreLegal
Regulatory compliance with translation for multiple jurisdictions
Learn how important AMGEN documents for regulatory compliance were professionally translated and verified using Guildhawk translation expertise.
Read MoreTranslation vs. verification
Most sponsors use both, depending on the study, the country and who produced the first draft.
We translate and certify
Send us the source document and the target countries. A life sciences linguist translates it, a second linguist reviews it, and we issue a certificate of accuracy ready for submission.
We verify your translation
Send us the source and an existing translation from your CRO, another vendor or your own machine translation tool. We check it line by line, correct it in tracked changes and certify the final version.
Running machine translation in house?
Many sponsors now translate trial documents with their own machine translation tools, with mandatory human quality control before release.
We act as that quality control step. Our linguists verify the output against the source and return corrections you can feed back into your translation memory, so quality and savings improve with every study.
Documents we translate and verify
From first patient documents to study close.
Informed consent forms
Main, optional, pregnant partner and future research consents, plus amendments
Assent forms
Age appropriate versions for paediatric and adolescent participants
Patient facing materials
Recruitment leaflets, patient cards, diaries and visit instructions
Protocols and synopses
Full protocols, synopses and protocol amendments
Investigator brochures
Including updated safety information for sites
Medical records
Certified translation for eligibility review and adjudication
Ethics and authority correspondence
Submission letters, queries and responses
Lay summaries
Plain language summaries of results for participants
What our verification checks
The errors that send a document back from an ethics committee are rarely about style. We check for them first.
Version and template
The translation matches the current master version, the correct country template, version numbers, dates and footers.
Dates, doses and schedules
Dosing, visit windows, procedure counts and date formats checked figure by figure against the source.
Completeness
No untranslated terms, missing sections, leftover comments or unaccepted tracked changes.
Medical terminology
Conditions, procedures and adverse events rendered consistently with the protocol and your approved glossary.
Participant readability
Consent language a lay participant can understand, without losing the meaning of risks and rights.
Country requirements
Local wording for data protection, insurance, compensation and contact details, as each trial country expects.
How it works
Built around submission deadlines, one study and one country at a time.
Send your files
Share the source, any existing translation and the target countries through our secure transfer.
Confirm scope
We confirm the deadline, the certification needed and a quote for that study and country.
Translate or verify
A life sciences linguist translates or checks the document against the source.
Report
You receive tracked changes and an issue log grading each finding by severity.
Certify
We issue a certificate of accuracy for the final version, ready to submit.
Built for clinical operations teams
Trial associates and trial managers across Europe send us their study documents directly.
One team for your studies
A dedicated mailbox and project team who know your templates, your glossary and your countries.
Consistent across amendments
Translation memory built on your studies keeps every ICF amendment consistent with the version before.
Confidential by design
Medical records and study documents handled under ISO 27001 certified controls and GDPR.
QUESTIONS
Frequently asked questions
What is the difference between translation and verification?
With translation, we produce the target document from your source. With verification, you already have a translation and we check it against the source, correct it and confirm it is fit to submit.
Can you verify translations from our CRO or machine translation tool?
Yes. We verify translations from any source, including other vendors, CROs and in house machine translation, and return tracked changes with an issue log.
Do you certify the final document?
Yes. We issue a certificate of accuracy for each verified or translated document, which ethics committees and authorities can rely on.
Do you offer back translation?
Yes, on request. An independent linguist translates the target back into the source language, and we provide a reconciliation report of any differences.
How quickly can you turn around an ICF?
It depends on length, language and whether it is a new document or an amendment. We confirm the deadline before we start, including urgent ethics committee submissions.
How do you protect patient data?
All documents, including medical records, are handled under ISO 27001 certified information security controls and in line with GDPR.
Contact us today
